CDC Analysis Suggests Fluoroquinolone Prescribing Continues Apace in the US, Despite FDA Warnings: Public Health Watch

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High prescribing continues despite the fact that heavy use of these agents can facilitate the development of multidrug-resistant bacteria and tendon, muscle, joint, and central nervous system damage.

In 2005, a review published in the journal Clinical Microbiology and Infection described fluoroquinolones as “some of the most important antimicrobial agents that we have for treatment of serious infections.”

However, in a statement that would prove prescient a scant few years later, the author would go on to write that “a growing concern is… [the] heavy use of these agents in association with increasing resistance to other agents… [which] can facilitate the development of multidrug-resistant [bacteria] and leave little available therapy for treatment of these infections.”

If that warning isn’t enough, there is also the issue of adverse events: In 2008, the US Food and Drug Administration (FDA) issued a boxed warning highlighting the risk for tendon, muscle, joint, and central nervous system damage associated with fluoroquinolones, a drug class that includes the agents, ciprofloxacin, levofloxacin, norfloxacin, and ofloxacin, among others. The FDA modified the warning in 2016, noting “that the serious side effects [with fluoroquinolones] … generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.”

Oddly enough, though, it seems that some health care professionals have failed to heed these warnings. A 2015 study, for example, found that in 2011 (the year assessed) fluoroquinolones were the third most commonly prescribed outpatient antibiotics for adult patients in the United States, with an estimated 115 prescriptions per 1,000 persons.

So where are we with fluoroquinolone use today?

New research performed by the US Centers for Disease Control and Prevention (CDC) aims to answer that very question. The authors analyzed data from the QuintilesIMS Xponent database, which includes figures on prescriptions dispensed in 2014 from 90% of retail pharmacies across the country, and diagnosis information from the CDC’s National Center for Health Statistics’ National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) for 2013 to 2014. NAMCS and NHAMCS also provide estimates on antibiotic prescribing in physician offices and emergency departments. The authors then identified diagnoses such as viral upper respiratory tract infections (URTIs) and bronchitis “for which no antibiotic therapy should be prescribed,” and diagnoses for which fluoroquinolones are not recommended, including sinusitis and uncomplicated cystitis in women.

What they found is troubling.

In 2014, retail pharmacies dispensed more than 31 million fluoroquinolones, with the highest percentage (24.5%) being used for “genitourinary conditions.” In all, some 1.5 million of these fluoroquinolone prescriptions were dispensed for sinusitis and more than 850,000 were dispensed for bronchitis. Another 750,000-plus were administered for viral URTIs. Together, viral URTIs and bronchitis accounted for 5.1% of all fluoroquinolone prescriptions dispensed in 2014—a full 6 years after the FDA issued its initial boxed warning.

What was the authors’ solution to this apparent contradiction to best practices?

“With the threats to patient safety and rising rates of antibiotic resistance, fluoroquinolones should not be prescribed for conditions where alternative effective therapies are recommended,” they write. “Antibiotic stewardship efforts should target inappropriate fluoroquinolone prescribing in adults, specifically for acute respiratory tract infections for which no antibiotics are needed, and for ambulatory infections for which fluoroquinolones are not recommended first-line therapy. This will optimize clinical outcomes by reducing unnecessary antibiotic therapy and preventing fluoroquinolone adverse drug reactions.”

In other words, follow the guidelines.

Sounds simple enough—except that if these data are any indication, providers simply aren’t getting it.

Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous health care-related publications. He is the former editor of Infectious Disease Special Edition.

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